Clinical trial · Interventional
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
Pilot Tests to Optimize the Delivery of Energy Balance Interventions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
This pilot clinical trial studies different types of energy balance interventions to see how well they work in increasing the physical activity levels of breast cancer gene-positive patients, Lynch syndrome-positive patients, chronic lymphocytic leukemia (CLL) survivors or family members of cancer survivors who are at high risk for cancer. Increasing exercise and eating healthy foods may help reduce the risk of cancer. Studying how well different types of interventions work in motivating cancer survivors or high-risk family members to increase exercise and healthy food choices may help doctors plan the most effective motivational program for cancer prevention.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Body Mass Index 25 or Greater | — | UNRESOLVED | — |
| BRCA1 Gene Mutation | — | UNRESOLVED | — |
| BRCA2 Gene Mutation | — | UNRESOLVED | — |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cancer Survivor | — | UNRESOLVED | — |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Fatigue | — | UNRESOLVED | — |
| Health Status Unknown | — | UNRESOLVED | — |
| Lynch Syndrome | — | UNRESOLVED |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary Intervention | Dietary Supplement | — | UNRESOLVED |
| Internet-Based Intervention | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Telephone-Based Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (energy balance interventions)
- description
- TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing. TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages. SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking. SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone app.
- interventionNames
- Dietary Supplement: Dietary Intervention
- Other: Internet-Based Intervention
- Other: Laboratory Biomarker Analysis
- Other: Questionnaire Administration
- Behavioral: Telephone-Based Intervention
Primary outcomes (2)
- measure
- Change in waist circumference (Pilot I)
- timeFrame
- Baseline to 4 months post-intervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * PILOTS I, II AND III: Body mass index (BMI) of 25 or higher OR \< 150 minutes of moderate to vigorous exercise per week OR \< 5 servings of fruit and vegetables per day * PILOTS I, II AND III: Capable of participating in moderate-vigorous unsupervised exercise * PILOTS I, II AND III: Have a cellular telephone and are able and willing to send and receive text messages * PILOTS I, II AND III: Able to read and write English * PILOTS I, II AND III: Have access to internet * PILOT II: BRCA positive OR Lynch syndrome positive individuals * PILOT II (FAMILY MEMBER): Female and male biological and non-biological family members of BRCA-positive individuals OR Lynch syndrome positive individuals * PILOT III: CLL survivors * PILOT III: Has experienced fatigue within the past seven days Exclusion Criteria: * PILOTS I, II AND III: Unable to walk without crutches, walker, cane, or other assistive device * PILOTS I, II AND III: Women who are pregnant (by self-report) * PILOTS I, II AND III: Less than 3 months post-surgery * PILOTS II and III: Currently receiving radiation therapy or cytotoxic chemotherapy
References
Publications (1)
- DERIVEDCrane JC, Gordon MJ, Basen-Engquist K, Ferrajoli A, Markofski MM, Lee CY, Fares S, Simpson RJ, LaVoy EC. Relationships between T-lymphocytes and physical function in adults with chronic lymphocytic leukemia: Results from the HEALTH4CLL pilot study. Eur J Haematol. 2023 Jun;110(6):732-742. doi: 10.1111/ejh.13958. Epub 2023 Mar 31. PMID 36946440